High dose oral colchicine has been utilized for the treatment of acute gouty arthritis for several centuries. Thisuse predates the rigorous FDA approval process in the recent decades, and so the manufacture, prescription,and use of colchicine were not rigorously evaluated in controlled settings. Toxicity studies have providedevidence of significant interactions between colchicine and other commonly used medications such as statinsand macrolides. In 2009 the FDA provided approval and market exclusivity for a single agent colchicinepreparation (Colcrys(R)) following studies that provided data to suggest that a) lower dose of Colcrys(R) may beas efficacious as the higher dose colchicine and that b) the adverse effects for lower dose colchicine may bemuch lower than that of the traditional high dose regiment. This has triggered a major controversy andquestions about the impact of the FDA Unapproved Drug Initiative. We propose to study the impact of theColcrys(R) approval, the related media publicity and the Phase 2 and 3 study data in real world gout flaretreatment. The first specific aim will be to use Stanford Medical Center electronic medical records to perform acomparison of colchicine utilization patterns before and after approval of Colcrys(R). The second specific aimwill be to perform a prospective observational study of patients with gout over a 3-year period in order toidentify the prevalence and risk factors for unsafe/unapproved colchicine use. This cohort study will besupplemented by a qualitative study that will identify the intangible factors such as health beliefs, health literacyand self-efficacy that are associated with unsafe/unapproved colchicine use. We hypothesize that we will beable to demonstrate large-scale improvements safety of colchicine use in clinical settings thereby providing anevidence base for the success of FDA Unapproved Drug Initiative and provide data for a root-cause analysisfor prevention of continuing unsafe use of this drug.
Colchicine, a common, potentially toxic treatment for gouty arthritis that affects over 8 million Americans has been brought under the purview of the FDA Unapproved Drug Initiative in 2009 but it is not known if this has resulted in safer utilization in clinical settings. Our study will assess the impact of this Initiative on colchicine use and will provide data that supports its continuation and expansion.
